BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT XG MONITOR

    MDR report key: 3091488 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00519
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 21, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SVC REPS REPLACED THE MAIN CPU BOARD. CALIBRATED FUNCTIONAL AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PASSPORT XG MONITOR WAS CONTINUOUSLY REBOOTING WHICH MAY HAVE RESULTED IN A LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187094 PASSPORT XG MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1